KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC November 6, 2018

Size: px
Start display at page:

Download "KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC November 6, 2018"

Transcription

1 KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC 2018 November 6,

2 FORWARD-LOOKING STATEMENTS To the extent statements contained in the following presentations are not descriptions of historical facts regarding OncoSec Medical Incorporated, they should be considered forward-looking statements, as described in the Private Securities Litigation Reform Act of 1995, that reflect management s current beliefs and expectations. You can identify forward-looking statements by words such as anticipate, believe, could, estimate, expect, forecast, goal, hope, hypothesis, intend, may, plan, potential, predict, project, should, strategy, will, would, or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements are not assurances of future performance and include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our and our partners ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of the markets for our product candidates, and our ability to serve those markets; (vi) the rate and degree of acceptance of our product candidates; (vii) our ability to attract and retain key scientific or management personnel; (viii) the anticipated timing of clinical data availability; (ix) the anticipated timing of commercial launch of ImmunoPulse IL-12; (x) our ability to meet our milestones; (xi) our expectations regarding our ability to obtain and maintain intellectual property protection; (xii) the level of our corporate expenditures; (xiii) the assessment of our technology by potential corporate partners; and (xiv) the impact of capital market conditions on us. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward looking statements. These statements are also subject to a number of material risks and uncertainties that are described in OncoSec s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to publicly update any forward-looking statements, except as required by law. OncoSec s investigational drug and device products have not been approved or cleared by the FDA.

3 KEYNOTE-695 Introduction Immune checkpoint inhibitors have become a mainstay in the treatment of melanoma 1 However, a high unmet medical need remains in metastatic melanoma - Most patients do not respond to immune checkpoint inhibition 2,3 - Attempts to potentiate activity by combining ipilimumab and nivolumab has resulted in significant toxicity 4 There is currently no approved therapy in the salvage setting for immune checkpoint inhibitor-refractory metastatic melanoma patient populations 1 - KOLs consider ~10% response rate clinically meaningful as this is what they could elicit with additional chemotherapy; however, responses achieved with chemotherapy are not durable 5 - Tolerability is an important consideration in this heavily pretreated population 1. NCCN Guidelines. Melanoma. v3.2018; 2. Schachter J, et al. Lancet. 2017;390(10105): ; 3. Weber J, et al. Lancet Oncol ; 17(7): ; 4. Shoushtari et al. JAMA Oncology 2017; 5. OncoSec, data on file. 3

4 Patient Eligibility Criteria WRT FDA Approved Anti-PD-1 Therapy Pathologically documented unresectable melanoma, Stage III/IV, with histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease All patients must be refractory to anti-pd-1 mabs (pembrolizumab or nivolumab according to their approved label) and must meet all of the following criteria: - Received 4+ doses of anti-pd-1 - Progressive disease after anti-pd-1 mab according to RECIST v1.1 - Documented disease progression 24 weeks of the last dose of anti-pd-1 No intervening therapies permitted in-between anti-pd-1 failure and TAVO/KEYTRUDA combination Prior treatment with an approved BRAF inhibitor if BRAF mutation-positive 4

5 KEYNOTE-695 Preliminary Data Interim data set as of September 1, enrolled, 19 patients treated - 9 patients evaluable for first scan, having completed 12 weeks of treatment Preliminary responses (based on RECIST v1.1) - 2/9 PRs and 1/9 SD (22% BORR and 33% DCR) at initial tumor evaluation (12 weeks of treatment) - Immunological response assessment correlated to observed clinical responses - Tumor responses observed in treated and untreated lesions - Preliminary response rates are strong in this salvage patient population Safety Profile - Nearly all Grade 1 AE s of predominately transient pain/discomfort - One TAVO related Grade 3 SAE of cellulitis was reported and resolved - With over a 150 patients treated with TAVO to date, other than two Grade 3 episode of cellulitis, which resolved completely, TAVO-related AEs have been limited to Grade 1, predominately injection site discomfort/pain Based on the outcome of the study and feedback from FDA, the Company plans to file for accelerated approval by end of 2019 or early

6 KEYNOTE-695: TAVO for Stage III/IV Melanoma Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study Single Arm Phase 2/3 study Primary outcome: BORR based on RECIST v1.1 Secondary outcomes: DOR, PFS and OS Eligible patients: anti-pd-1 non-responders with stage III/IV melanoma - Received 4+ doses of anti-pd-1 - Progressive disease according to RECIST v1.1 - Documented disease progression 24 weeks of the last dose of anti-pd-1 - No intervening therapies permitted in-between checkpoint failure and TAVO/KEYTRUDIA combination TAVO TAVO TAVO Orphan designation Fast Track Breakthrough status Accelerated pathway Approximately 80 patients Dosing ongoing in ~20 sites (U.S. Australia & Canada) Top, preliminary data at SITC 2018 Complete enrollment by mid-2019 P = Pembrolizumabtreatment Positive outcome may support accelerated filing by end 2019/early

7 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 7

8 Overview Patient # Male 65yrs Stage at screening Stage IVB Metastatic disease in lymph nodes (distant), lung and subcutaneous Medical history hip replacement, thumb infection, enlarged prostate, removal of BCC on the neck Prior surgery on lesion on abdominal wall, dissection left groin, sentinel & right axillary lymph node. No radiotherapy. Prior Systemic therapy Pembrolizumab 150 mg IV for 7 cycles => PD 8

9 Medical History 65 year-old white male with Stage IVB melanoma ( ) Medical History: Melanoma History: February 2014 Diagnosis melanoma Excision of primary lesion right abdominal wall Osteoarthritis with bilateral hip replacements Benign prostatic hyperplasia Basal cell carcinoma Spontaneous pneumothorax September 2016 Local recurrence: Excision right abdominal wall October 2017 Distant recurrence: Excision subcutaneous lesion in left forearm Distant LN, lung metastases February 2018 Disease progression in LN and lungs after 7 cycles Clinical trial OMS-I103 March 2014 Wide local resection right abdominal wall Sentinel LN dissection left groin Pembrolizumab 150 mg IV Q3 wk May 2017 (13 Oct Feb 2018) Local recurrence: Wide 7 cycles excision right abdominal wall Right axillary node dissection IV, intravenous; LN, lymph node; Q3 wk, every 3 weeks. 9

10 Measures and PI ORR Assessment Patient # Cycle 5 (2 TAVO treatments) Target Lesion PR Non target lesion non CR / non PR No new lesions Measures TL1 skin (treated) TL2 skin (treated) TL3 lymph (untreated) Baseline 16mm 25mm 28mm Cycle 5 (~12 wks) 4mm 27mm 6mm 10

11 Clinical Trial Experience and 12-week Response Patient # April 2018: Screening Melanoma, Stage IVB, with subcutaneous lesions, lung and LN involvement ECOG PS: 0 16 April July 2018 Treatment as per protocol Cycle 1 5 IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle Adverse events Cycle 1 5 Grade 1 injection site pain Investigator deemed related to process of EP and not to the injected treatment April July July 2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: PR* 46.4% decrease in sum of diameters Abscopal effect Non target lesions: non CR/ non PR No new lesions identified * RECIST 1.1 = PR; irecist = ipr Continue treatment as per protocol Longest diameter*, mm TL1 (subcutaneous) TL2 (subcutaneous) TL3 (LN) Sum of TL Baseline weeks *LN is measured per RECIST 1.1 on shortest axis. CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; i, Immune; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumor; tavo, plasmid interleukin-12; TL, target lesion. 11

12 Images of Baseline vs. 12 Week Assessment Lesions Patient # Baseline Placeholder for CT TL3 baseline 12 weeks Lesion #1: No photo available due to the tumor being undetectable post treatment. Placeholder for CT TL3 12 weeks 12

13 CT Images of Baseline vs. 12 Week Assessment Lesions Patient # Pre-Treatment 12 Weeks TL1 TL1 TL3 (untreated) Pre-Treatment 12 Weeks TL2 The untreated lesion is a left hilar node, far away from the treated lesions. 13

14 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 14

15 Overview Patient # Female 71yrs Stage at screening Stage IVB Metastatic disease in lymph nodes (distant), lung and subcutaneous Medical history hypothyroidism, Vaginal prolapse, BCC, SCC Prior surgery on skin excisions, wide excisions. No radiotherapy. Prior Systemic therapy Pembrolizumab 150 mg IV for 9 cycles Ipilimumab & nivolumab 4 cycles Nivolumab 2 cycles => PD 15

16 Medical History 71 Year-old White Female with Stage IVB Melanoma ( ) Medical History: Melanoma History: October 2015 Diagnosis of melanoma Skin excision Hypothyroidism Multiple basal cell carcinomas and squamous cell carcinomas Vaginal prolapse Constipation, insomnia, anxiety, and night sweats Adjuvant Pembrolizumab 2 mg/kg IV Q3 wk (Apr Sep 2017) 9 cycles Ipilimumab 3 mg/kg IV Q3 wk Nivolumab 1 mg/kg IV Q3 wk (23 Oct Dec 2017) 4 cycles May 2017 Distant Recurrence: IVA Nivolumab 3 mg/kg IV Q2 wk (15 Jan Feb 2018) 2 cycles Clinical trial OMS-I103 November 2015 Wide local excision March 2017 Local recurrence: Wide excision of forehead 3 core biopsies IV, intravenous; Q2 wk, every 2 weeks; Q3 wk, every 3 weeks. 16

17 Measures and PI ORR Assessment Patient # Cycle 5 (2 TAVO treatments) Target Lesion PR Non target lesion non CR / non PR No new lesions Measures TL1 skin TL3 skin Baseline 32mm 24mm Cycle 5 (~12 wks) 22mm 17mm 17

18 Clinical Trial Experience and 12-week Response Patient # May 2018: Screening Melanoma, stage IVA, with skin lesions ECOG PS: 0 24 May August 2018 Treatment as per protocol Cycle 1 5 IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle Adverse events Cycle 1 5 Grade 1 pruritis: related to pembrolizumab; not related to TAVO or EP Grade 1 night sweats: not related to any of the treatments or EP Grade 2 diarrhea: related to pembrolizumab and TAVO; not related to EP May August August2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: PR* 30% decrease in sum of diameters Non target lesions: non-cr/non- PD No new lesions * RECIST 1.1 = PR; irecist = ipr Continue treatment as per protocol Longest diameter, mm TL1 (skin) TL3 (skin) Sum of diameters TL Baseline weeks CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; i, Immune; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; NTL, non-target lesion; PR, partial response; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumor; tavo, plasmid interleukin-12; TL, target lesion. 18

19 Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images ( ) Baseline 12 weeks 19

20 Axial Images Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images ( ) Axial images from patient # showing large exophytic scalp lesions. 20

21 Intratumoral Gene Expression Patient # Intratumoral gene expression in a PR demonstrates increased antigen presentation and T cell activation / trafficking 21

22 Intratumoral Gene Expression Patient # Intratumoral gene expression in a PR demonstrates a treatment-related increase in adaptive resistance 22

23 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 23

24 Overview Patient # year-old white male with stage IVA melanoma 10 cycles of pembro 200 mg Surgery arm for melanoma / axillary clearance / axillary SLNB No radiation therapy 16Jul2018 (cycle 5, day 1): Target lesion: SD (0% decrease in sum of diameters) Non target lesions: non CR / non PD No new lesions TL1 skin TL2 skin Sum of TL Screening 19 mm 11 mm 30 mm Cycle 5 19 mm 11mm 30 mm 24

25 Multispectral IHC Patient # Multispectral IHC: patient has an immuno-active lesion after a single cycle of treatment 25

26 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 26

27 Overview Patient year-old white male with stage IVB melanoma 4 cycles of pembro 210 mg Surgery Lymph node / heel No radiation therapy 16Mar2018 (cycle 5, day 1): Target lesions: Stable Disease (13% decrease in sum of diameters) Non target lesions: non CR / non PD New lesions: yes but isd Patient is still on treatment Baseline 12 weeks TL1 skin Sum of TL Screening 23 mm 23 mm Cycle 5 20 mm 20 mm isd, Immuno-Stable Disease 27

28 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 28

29 Overview Patient # year-old white female with stage IVC melanoma Prior treatments: Temozolmide 4 cycles Nivolumab 18 cycles Ipi 3 cycles Trametinib / IL-2 2 cycles Epadacostst 4 cycles Interferons / pembrolizumab 4 cycles Ipi & nivo 4 cycles Surgery intussusception repair No radiation therapy Patient receive only sub-optimal dose of TAVO due to difficulty in administration Aug 2018 (cycle 5, day 1): Target lesions: SD (<10% decrease in sum of diameters) TL1 skin TL2 TL4 Non target lesions: non CR / non PD Screening 82 mm 28 mm 22 mm New lesions and patient withdrew Cycle 5 pending pending pending 29

30 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 30

31 Overview Patient # year-old white male with stage IVB melanoma Prior treatments: Encorafenib 2 cycles Binimetinib 2 cycles Dabrafenib 30 cycles Trametinib 30 cycles Pembrolizumab 18 cycles [200mg] Surgery scalp No radiation therapy Aug 2018 (cycle 5, day 1): Target lesion: SD (0% decrease in sum of diameters) Non target lesion: NE New lesions Patient withdrew from study TL1 skin TL2 SUM TL Screening 20 mm 14 mm 34 mm Cycle 5 18 mm 15 mm 33mm 31

32 KEYNOTE-695 Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SD iupd; isd (SD TL / new NTL) iupd; WDC (PR TL / new NTL) iupd; WDC (SD TL / new NTL) PD PD PD SUMMARY OF RESPONSE 2 PR 1 SD 3 iupd 3 PD PR, partial response; SD, Stable Disease; TL, target lesion; NTL, non-target lesion; PD, Progressive Disease; WDC, Withdrew consent; iupd, immunologic unconfirmed progressive disease. 32

33 74 year-old white female with stage IIIC melanoma Prior treatment: Pembrolizumab 4 cycles Ipi & nivo 4 cycles Surgery No radiation therapy April 2018 (cycle 5, day 1): Target lesions: PD Non target lesions: PD New lesions No longer on treatment Overview Patient # TL5 skin TL2 TL3 (vaginal mass) Screening 15 mm 69 mm 22 mm EOS 15 mm 84 mm 24 mm 33

34 61 year-old white female with stage IVA melanoma Prior treatment: Pembrolizumab 11 cycles Ipi 4 cycles Nivo 16 cycles Surgery / groin excision / subcut mets No radiation therapy Mar2018 (cycle 5, day 1): Target lesions: SD Non target lesions: non CR / non PD New lesions No longer on treatment Overview Patient # Screening Cycle 5 TL15 skin 13 mm 13 mm 34

35 ORR and Tumor Measures 71 Year-old White Male with Stage IVA Melanoma ( ) Baseline Images Cycle 5 Images TL1 LN TL3 skin SC TL4 skin TL5 skin SC TL9 skin Sum of TL Screening 31mm 71mm 24mm 33mm 39mm 198 Cycle 5 35mm 47mm 11mm 41mm 42mm Jul2018 (cycle 5, day 1): Tumor response at 12 weeks Target lesions: SD 11% decrease in sum of diameters Non target lesions: PD New lesions Patient was found to have a new lytic lesion in the distal femur. The lesion was examined and determined to be high potential for a pathological femoral fracture and patient was electively hospitalized, underwent left femoral intramedullary rod insertion, and could no longer be treated. TL, target lesion; NTL, non-target lesion; SD, stable disease; PS, performance status; iupd, immunologic unconfirmed progressive disease; ORR, overall response rate 35

36 CD3 + /CD8 + /PD- Immunologic Impact via mihc Patient # Screen Tumoral PD C2D1 L mihc Demonstrates a Powerful Treatment-related Increase in TIL Density with 1 Cycle of TAVO /PEMBRO in an Immunologically Cold Lesion 36

37 PRELIMINARY SAFETY 37

38 KEYNOTE-695 TAVO + Pembrolizumab Tolerability in Patients Who Completed 12 Weeks of Treatment TAVO related AEs Pembrolizumab-related AEs Total AEs/SAEs related to study drugs Grade 1, n (%) 5/9 (55.6) 3/9 (33.3) 8/9 (88.9) Grade 3, n (%) 1/9 (11.1) 2/9 (22.2) 3/9 (33.3) TAVO -related AEs were limited to grade 1 injection site discomfort/pain, except for one grade 3 episode of cellulitis, which resolved completely 38

39 ADDITIONAL PRELIMINARY BIOMARKER DATA 39

40 A treatment-related upregulation of immune-based transcripts in the tumor microenvironment was observed in 7 matched biopsies 40

41 IHC: PR Has Increase in the Density of CD8 + TILs PD PR PD SD 41

42 IHC: PR/SD Have Increased PD-L1 + Tumor Cells PR PD PD SD 42

43 gmdsc Reduced in PR/SD Patients Partial Response ( ) Screen C2D 1 Progressive Disease ( ) Screen C2D 1 Stable Disease ( ) Screen C2D 1 Progressive Disease (61-007x-102) Screen C2D 1 43

44 Decreased Monocytes/Macrophages in PR/SD Partial Response ( ) Screen C2D1 Progressive Disease ( ) Screen C2D1 Stable Disease ( ) Screen C2D1 Progressive Disease ( ) Screen C2D1 44

45 Increased Frequency of Peripheral CD8 + T Cells in PR/SD Patients After 1 Cycle of Treatment PR ( ) SD ( ) PD ( ) PD ( ) 45

Targeting the Tumor Locally

Targeting the Tumor Locally ARMING THE IMMUNE SYSTEM TO FIGHT CANCER Targeting the Tumor Locally October 2017 NASDAQ:ONCS Cautionary Note Regarding Forward-Looking Statements To the extent statements contained in the following presentations

More information

Targeting the Tumor Locally

Targeting the Tumor Locally Targeting the Tumor Locally Cautionary Note Regarding Forward-Looking Statements To the extent statements contained in the following presentations are not descriptions of historical facts regarding OncoSec

More information

8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks

8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks October 19, 2017 OncoSec Presents Positive Phase 2 Data for ImmunoPulse IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non- Responder

More information

Targeting the Tumor Locally

Targeting the Tumor Locally ARMING THE IMMUNE SYSTEM TO FIGHT CANCER Targeting the Tumor Locally September 2017 NASDAQ:ONCS Cautionary Note Regarding Forward-Looking Statements To the extent statements contained in the following

More information

Targeting the Tumor Locally. April 2018 NASDAQ:ONCS

Targeting the Tumor Locally. April 2018 NASDAQ:ONCS Targeting the Tumor Locally April 2018 NASDAQ:ONCS Cautionary Note Regarding Forward-Looking Statements To the extent statements contained in the following presentations are not descriptions of historical

More information

OncoSec Provides 2018 Business Outlook

OncoSec Provides 2018 Business Outlook January 3, 2018 OncoSec Provides 2018 Business Outlook Complete stage 1 enrollment of PISCES/KEYNOTE-695 clinical trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) Present preliminary

More information

Idera Pharmaceuticals

Idera Pharmaceuticals Idera Pharmaceuticals ILLUMINATE-204 Clinical Data Update December 2018 Forward Looking Statements and Other Important Cautions This presentation contains forward-looking statements within the meaning

More information

NY-ESO SPEAR T-cells in Synovial Sarcoma

NY-ESO SPEAR T-cells in Synovial Sarcoma NY-ESO SPEAR T-cells in Synovial Sarcoma ASCO Update June 6, 2017 Disclaimer This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform

More information

The Galectin-3 Inhibitor GR-MD-02 for Combination Cancer Immunotherapy

The Galectin-3 Inhibitor GR-MD-02 for Combination Cancer Immunotherapy The Galectin-3 Inhibitor GR-MD-02 for Combination Cancer Immunotherapy Supplemental Information to Corporate Presentation February 6, 2018 NASDAQ: GALT www.galectintherapeutics.com 2018 2017 Galectin Therapeutics

More information

Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories

Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies Eric H. Rubin, MD Merck Research Laboratories Outline Pembrolizumab P001 study - example of multiple expansion

More information

First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor

First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor September 30, 2014 Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy @ (ipilimumab) Presented at the ESMO 2014 Congress First Phase 3 Results Presented

More information

NewLink Genetics Corporation

NewLink Genetics Corporation Cantor Fitzgerald 2018 Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK October 3, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking

More information

Immunotherapy for the Treatment of Melanoma. Marlana Orloff, MD Thomas Jefferson University Hospital

Immunotherapy for the Treatment of Melanoma. Marlana Orloff, MD Thomas Jefferson University Hospital Immunotherapy for the Treatment of Melanoma Marlana Orloff, MD Thomas Jefferson University Hospital Disclosures Immunocore and Castle Biosciences, Consulting Fees I will be discussing non-fda approved

More information

Immunotherapy for the Treatment of Head and Neck Cancers. Robert F. Taylor, MD Aurora Health Care

Immunotherapy for the Treatment of Head and Neck Cancers. Robert F. Taylor, MD Aurora Health Care Immunotherapy for the Treatment of Head and Neck Cancers Robert F. Taylor, MD Aurora Health Care Disclosures No relevant financial relationships to disclose I will be discussing non-fda approved indications

More information

NewLink Genetics Corporation

NewLink Genetics Corporation Cantor Fitzgerald Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK September 25, 2017 Forward-Looking Disclaimer This presentation contains forward-looking statements of NewLink that

More information

Idera Pharmaceuticals. ASCO 2018 Annual Meeting Investor/Analyst Event

Idera Pharmaceuticals. ASCO 2018 Annual Meeting Investor/Analyst Event Idera Pharmaceuticals ASCO 2018 Annual Meeting Investor/Analyst Event Forward Looking Statements and Other Important Cautions This presentation contains forward-looking statements within the meaning of

More information

Checkpoint Regulators Cancer Immunotherapy takes centre stage. Dr Oliver Klein Department of Medical Oncology 02 May 2015

Checkpoint Regulators Cancer Immunotherapy takes centre stage. Dr Oliver Klein Department of Medical Oncology 02 May 2015 Checkpoint Regulators Cancer Immunotherapy takes centre stage Dr Oliver Klein Department of Medical Oncology 02 May 2015 Adjuvant chemotherapy improves outcome in early breast cancer FDA approval of Imatinib

More information

REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES

REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES May 18, 2017 Molecularly Defined Solid Tumor Program Update FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations,

More information

Immunotherapy in Unresectable or Metastatic Melanoma: Where Do We Stand? Sanjiv S. Agarwala, MD St. Luke s Cancer Center Bethlehem, Pennsylvania

Immunotherapy in Unresectable or Metastatic Melanoma: Where Do We Stand? Sanjiv S. Agarwala, MD St. Luke s Cancer Center Bethlehem, Pennsylvania Immunotherapy in Unresectable or Metastatic Melanoma: Where Do We Stand? Sanjiv S. Agarwala, MD St. Luke s Cancer Center Bethlehem, Pennsylvania Overview Background Immunotherapy clinical decision questions

More information

Leading the Next Wave of Biotech Breakthroughs

Leading the Next Wave of Biotech Breakthroughs Leading the Next Wave of Biotech Breakthroughs Corporate Extensive corporate assets Platforms Pipeline Partnerships Building a sustainable global business Platform licenses represent a source of non-dilutive

More information

Wells Fargo Healthcare Conference September 6, 2018

Wells Fargo Healthcare Conference September 6, 2018 Wells Fargo Healthcare Conference September 6, 2018 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are

More information

Corporate Presentation

Corporate Presentation Corporate Presentation Leerink Global Healthcare Conference February 14 th -15 th, 2018 C O N F I D E N T I A L a n d P R O P R I E T A R Y Forward Looking Statements / Safe Harbor This presentation contains

More information

Melanoma: Therapeutic Progress and the Improvements Continue

Melanoma: Therapeutic Progress and the Improvements Continue Melanoma: Therapeutic Progress and the Improvements Continue David W. Ollila, MD Professor of Surgery Jesse and James Millis Professor of Melanoma Research May 20, 2016 Disclosures: NONE Outline 2016 Therapeutic

More information

NewLink Genetics Corporation

NewLink Genetics Corporation Stifel Healthcare Conference Presentation NewLink Genetics Corporation NASDAQ: NLNK November 13, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements

More information

Dr Rosalie Stephens. Mr Richard Martin. Medical Oncologist Auckland City Hospital Auckland

Dr Rosalie Stephens. Mr Richard Martin. Medical Oncologist Auckland City Hospital Auckland Dr Rosalie Stephens Medical Oncologist Auckland City Hospital Auckland Mr Richard Martin General Surgeon Melanoma Unit Team Waitemata District Health Board Auckland 8:30-9:25 WS #99: Interactive Case Studies

More information

AACR 2018 Investor Meeting

AACR 2018 Investor Meeting AACR 218 Investor Meeting April 16, 218 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for

More information

Update on Immunotherapy in Advanced Melanoma. Ragini Kudchadkar, MD Assistant Professor Winship Cancer Institute Emory University Sea Island 2017

Update on Immunotherapy in Advanced Melanoma. Ragini Kudchadkar, MD Assistant Professor Winship Cancer Institute Emory University Sea Island 2017 Update on Immunotherapy in Advanced Melanoma Ragini Kudchadkar, MD Assistant Professor Winship Cancer Institute Emory University Sea Island 2017 1 Outline Adjuvant Therapy Combination Immunotherapy Single

More information

IMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

IMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases November 2017 Forward-Looking Statements This presentation, in addition to historical information, contains certain

More information

2019 ASCO-SITC. Nektar Therapeutics Investor & Analyst Call. March 1, 2019

2019 ASCO-SITC. Nektar Therapeutics Investor & Analyst Call. March 1, 2019 Nektar Therapeutics Investor & Analyst Call March 1, 2019 This presentation includes forward-looking statements regarding Nektar s proprietary drug candidates, the timing of the start and conclusion of

More information

Merck ASCO 2015 Investor Briefing

Merck ASCO 2015 Investor Briefing Merck ASCO 2015 Investor Briefing Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation

More information

Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know

Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know Jeffrey Weber, MD, PhD Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center New York, New York What Is the Current

More information

Reflex Testing Guidelines for Immunotherapy in Non-Small Cell Lung Cancer

Reflex Testing Guidelines for Immunotherapy in Non-Small Cell Lung Cancer Reflex Testing Guidelines for Immunotherapy in Non-Small Cell Lung Cancer Jimmy Ruiz, MD Assistant Professor Thoracic Oncology Program Wake Forest Comprehensive Cancer Center Disclosures I have no actual

More information

Combining HS-110 and anti-pd-1 in NSCLC. September 1, 2015

Combining HS-110 and anti-pd-1 in NSCLC. September 1, 2015 Combining HS-110 and anti-pd-1 in NSCLC September 1, 2015 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking

More information

Recurrent Ovarian Cancer Phase 1b Results

Recurrent Ovarian Cancer Phase 1b Results Recurrent Ovarian Cancer Phase 1b Results December 5 th, 2017 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine

More information

CheckMate 012: Safety and Efficacy of First Line Nivolumab and Ipilimumab in Advanced Non-Small Cell Lung Cancer

CheckMate 012: Safety and Efficacy of First Line Nivolumab and Ipilimumab in Advanced Non-Small Cell Lung Cancer CheckMate 12: Safety and Efficacy of First Line Nivolumab and Ipilimumab in Advanced Non-Small Cell Lung Cancer Abstract 31 Hellmann MD, Gettinger SN, Goldman J, Brahmer J, Borghaei H, Chow LQ, Ready NE,

More information

Checkpoint regulators a new class of cancer immunotherapeutics. Dr Oliver Klein Medical Oncologist ONJCC Austin Health

Checkpoint regulators a new class of cancer immunotherapeutics. Dr Oliver Klein Medical Oncologist ONJCC Austin Health Checkpoint regulators a new class of cancer immunotherapeutics Dr Oliver Klein Medical Oncologist ONJCC Austin Health Cancer...Immunology matters Anti-tumour immune response The participants Dendritc cells

More information

July, ArQule, Inc.

July, ArQule, Inc. July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical

More information

Assessment of Efficacy and Immune Related RECIST criteria

Assessment of Efficacy and Immune Related RECIST criteria Assessment of Efficacy and Immune Related RECIST criteria Dr Kenneth O Byrne Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia & Trinity College, Dublin, Ireland

More information

Immunotherapy for Breast Cancer. Aurelio B. Castrellon Medical Oncology Memorial Healthcare System

Immunotherapy for Breast Cancer. Aurelio B. Castrellon Medical Oncology Memorial Healthcare System Immunotherapy for Breast Cancer Aurelio B. Castrellon Medical Oncology Memorial Healthcare System Conflicts Research support : Cascadian therapeutics, Puma biotechnology, Odonate therapeutics, Pfizer,

More information

Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment

Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment 1 Introductions Peter Langecker, MD, PhD Executive Medical Director, Global Oncology Clinipace Worldwide Mark Shapiro Vice President

More information

Determined to realize a future in which people with cancer live longer and better than ever before

Determined to realize a future in which people with cancer live longer and better than ever before Determined to realize a future in which people with cancer live longer and better than ever before 4Q 2016 EARNINGS PRESENTATION MARCH 2017 1 Forward-looking statements disclosure This presentation contains

More information

Immunotherapy for the Treatment of Head and Neck Cancers. Barbara Burtness, MD Yale University

Immunotherapy for the Treatment of Head and Neck Cancers. Barbara Burtness, MD Yale University Immunotherapy for the Treatment of Head and Neck Cancers Barbara Burtness, MD Yale University Disclosures AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co., Inc.,

More information

Leerink Immuno-Oncology Roundtable Conference

Leerink Immuno-Oncology Roundtable Conference Leerink Immuno-Oncology Roundtable Conference September 28, 2017 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private

More information

Immunotherapy of Melanoma Sanjiv S. Agarwala, MD

Immunotherapy of Melanoma Sanjiv S. Agarwala, MD Immunotherapy of Melanoma Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Luke s Cancer Center, Bethlehem, PA Overview Metastatic Melanoma

More information

Melanoma. Il parere dell esperto. V. Ferraresi. Divisione di Oncologia Medica 1

Melanoma. Il parere dell esperto. V. Ferraresi. Divisione di Oncologia Medica 1 Melanoma Il parere dell esperto V. Ferraresi Divisione di Oncologia Medica 1 MELANOMA and ESMO 2017.what happens? New data and updates ADJUVANT THERAPY with CHECKPOINT INHIBITORS (CA209-238 trial) AND

More information

Ipilimumab ASCO Data Review and Discussion Webcast. Monday, June 2, 2008

Ipilimumab ASCO Data Review and Discussion Webcast. Monday, June 2, 2008 Ipilimumab ASCO Data Review and Discussion Webcast Monday, June 2, 2008 Slide 2 Forward Looking Statements Except for historical information, the matters contained in this slide presentation may constitute

More information

Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy

Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy Company Overview, September 2018 Safe Harbor Statement This presentation contains forward-looking

More information

ARQ 087 Overview. FGFR Inhibitor. March 2017

ARQ 087 Overview. FGFR Inhibitor. March 2017 ARQ 087 Overview FGFR Inhibitor March 2017 Safe Harbor This presentation and other statements by ArQule contain forward-looking statements within the meaning of the Private Securities Litigation Reform

More information

New Data from Ongoing Melanoma Study and Clinical Development Strategy Update

New Data from Ongoing Melanoma Study and Clinical Development Strategy Update New Data from Ongoing Melanoma Study and Clinical Development Strategy Update Webcast - 29 th / 30 th May 2018 (ASX: IMM, NASDAQ: IMMP) Notice: Forward Looking Statements The purpose of the presentation

More information

ONCOSEC ARMING THE IMMUNE SYSTEM TO FIGHT CANCER NASDAQ: ONCS

ONCOSEC ARMING THE IMMUNE SYSTEM TO FIGHT CANCER NASDAQ: ONCS ONCOSEC TM ARMING THE IMMUNE SYSTEM TO FIGHT CANCER NASDAQ: ONCS 0 Forward Looking Statements Our commentary and responses to your questions may contain forward looking statements, as described in the

More information

Management of Brain Metastases Sanjiv S. Agarwala, MD

Management of Brain Metastases Sanjiv S. Agarwala, MD Management of Brain Metastases Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Luke s Cancer Center, Bethlehem, PA, USA Incidence (US):

More information

Targeting and Treating Cancer

Targeting and Treating Cancer Targeting and Treating Cancer Mark R. Baker, Chief Executive Officer Jefferies Healthcare Conference June 2015 Disclosure Notice This presentation may contain projections and other forward-looking statements

More information

Current Trends in Melanoma Theresa Medina, MD UCD Cutaneous Oncology

Current Trends in Melanoma Theresa Medina, MD UCD Cutaneous Oncology Current Trends in Melanoma Theresa Medina, MD UCD Cutaneous Oncology Overview Melanoma incidence and prevention Approach to surgical management of early melanoma Landscape of Advanced Melanoma Therapy

More information

Single Technology Appraisal (STA) Nivolumab for adjuvant treatment of resected stage III and IV melanoma

Single Technology Appraisal (STA) Nivolumab for adjuvant treatment of resected stage III and IV melanoma Single Technology Appraisal (STA) Nivolumab for adjuvant treatment of resected stage III and IV Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) Comment:

More information

III Sessione I risultati clinici

III Sessione I risultati clinici 10,30-13,15 III Sessione I risultati clinici Moderatori: Michele Maio - Valter Torri 10,30-10,45 Melanoma: anti CTLA-4 Vanna Chiarion Sileni Vanna Chiarion Sileni IOV-IRCCS,Padova Vanna.chiarion@ioveneto.it

More information

33 rd Annual J.P. Morgan Healthcare Conference. January 2015

33 rd Annual J.P. Morgan Healthcare Conference. January 2015 33 rd Annual J.P. Morgan Healthcare Conference January 2015 Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management.

More information

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma Application includes CheckMate -066,

More information

MELANOMA: THE BEST OF THE YEAR Dott.ssa Silvia Quadrini UOC Oncologia ASL Frosinone

MELANOMA: THE BEST OF THE YEAR Dott.ssa Silvia Quadrini UOC Oncologia ASL Frosinone MELANOMA: THE BEST OF THE YEAR 2018 Dott.ssa Silvia Quadrini UOC Oncologia ASL Frosinone The Best of the Year 2018: MELANOMA CHIRURGIA TERAPIA ADIUVANTE TERAPIA PER MALATTIA AVANZATA The Best of the Year

More information

Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference

Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference Merck Announces FDA Approval of KEYTRUDA Provided to Investors as a Reference Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions

More information

MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018

MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018 MERCK ONCOLOGY OVERVIEW ASCO 218 JUNE 4, 218 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes forward

More information

Talimogene Laherparepvec (T-VEC) at the SCCA: an update

Talimogene Laherparepvec (T-VEC) at the SCCA: an update Talimogene Laherparepvec (T-VEC) at the SCCA: an update Jennifer M. Gardner, MD Assistant Professor, Division of Dermatology University of Washington jen1110@uw.edu Northwest Melanoma Symposium: Science

More information

Electro-Gene Therapy with IL-12 plasmid in metastatic melanoma

Electro-Gene Therapy with IL-12 plasmid in metastatic melanoma Electro-Gene Therapy with IL-12 plasmid in metastatic melanoma Adil Daud MBBS Clinical Professor of Medicine and Dermatology University of California, San Francisco Disclosures Advisory Boards OncoSec,

More information

PTAC meeting held on 5 & 6 May (minutes for web publishing)

PTAC meeting held on 5 & 6 May (minutes for web publishing) PTAC meeting held on 5 & 6 May 2016 (minutes for web publishing) PTAC minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and

More information

ASCO / COLUMBUS ENCORE PRESENTATION June 4, 2018

ASCO / COLUMBUS ENCORE PRESENTATION June 4, 2018 ASCO / COLUMBUS ENCORE PRESENTATION June 4, 2018 SAFE HARBOR STATEMENT Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions of the Private

More information

NSCLC: immunotherapy as a first-line treatment. Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To)

NSCLC: immunotherapy as a first-line treatment. Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To) NSCLC: immunotherapy as a first-line treatment Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To) The 800-pound gorilla Platinum-based chemotherapy is the SOC for 1st-line therapy in

More information

Role of the Pathologist in Guiding Immuno-oncological Therapies. Scott Rodig MD, PhD

Role of the Pathologist in Guiding Immuno-oncological Therapies. Scott Rodig MD, PhD Role of the Pathologist in Guiding Immuno-oncological Therapies Scott Rodig MD, PhD Department of Pathology, Brigham & Women s Hospital Center for Immuno-Oncology, Dana-Farber Cancer Institute Associate

More information

Evan J. Lipson, M.D.

Evan J. Lipson, M.D. Update on treatment for Merkel cell, cutaneous squamous cell and basal cell cancers Evan J. Lipson, M.D. The Johns Hopkins University School of Medicine Bloomberg~Kimmel Institute for Cancer Immunotherapy

More information

Treatment and management of advanced melanoma: Paul B. Chapman, MD Melanoma Clinical Director, Melanoma and Immunotherapeutics Service MSKCC

Treatment and management of advanced melanoma: Paul B. Chapman, MD Melanoma Clinical Director, Melanoma and Immunotherapeutics Service MSKCC Treatment and management of advanced melanoma: 2018 Paul B. Chapman, MD Melanoma Clinical Director, Melanoma and Immunotherapeutics Service MSKCC Disclosure Paul B. Chapman, MD Nothing to disclose. Off

More information

Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab)

Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab) Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab) Ongoing ENCORE 601 biomarker analyses suggest enhanced clinical benefit in subpopulation

More information

Melanoma: From Chemotherapy to Targeted Therapy and Immunotherapy. What every patient needs to know. James Larkin

Melanoma: From Chemotherapy to Targeted Therapy and Immunotherapy. What every patient needs to know. James Larkin Melanoma: From Chemotherapy to Targeted Therapy and Immunotherapy What every patient needs to know James Larkin Melanoma Therapy 1846-2017 Surgery 1846 Cytotoxic Chemotherapy 1946 Checkpoint Inhibitors

More information

Immuno-Oncology Applications

Immuno-Oncology Applications Immuno-Oncology Applications Lee S. Schwartzberg, MD, FACP West Clinic, P.C.; The University of Tennessee Memphis, Tn. ICLIO 1 st Annual National Conference 10.2.15 Philadelphia, Pa. Financial Disclosures

More information

ONCOS-102 in melanoma Dr. Alexander Shoushtari. 4. ONCOS-102 in mesothelioma 5. Summary & closing

ONCOS-102 in melanoma Dr. Alexander Shoushtari. 4. ONCOS-102 in mesothelioma 5. Summary & closing ONCOS-102 in melanoma Dr. Alexander Shoushtari 4. ONCOS-102 in mesothelioma 5. Summary & closing 1 Preliminary data from C824 Activating the Alexander Shoushtari, MD Assistant Attending Physician Melanoma

More information

Phase 1b KEYNOTE-200 (STORM):

Phase 1b KEYNOTE-200 (STORM): Phase 1b KEYNOTE-2 (STORM): A study of an intravenously delivered oncolytic virus, Coxsackievirus A21 in combination with pembrolizumab in advanced cancer patients Hardev S. Pandha 1, Kevin J. Harrington

More information

Third Quarter 2015 Earnings Call. November 9, 2015

Third Quarter 2015 Earnings Call. November 9, 2015 Third Quarter 2015 Earnings Call November 9, 2015 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements

More information

Coxsackievirus A21: The basic facts

Coxsackievirus A21: The basic facts Phase II CALM Extension study: Intratumoral CAVATAK TM increases immune- cell infiltrates and up- regulates immune- checkpoint molecules in the microenvironment of lesions from advanced melanoma padents

More information

Eligibility Form. 1. Patient Profile. (This form must be completed before the first dose is dispensed.) Request prior approval for enrolment

Eligibility Form. 1. Patient Profile. (This form must be completed before the first dose is dispensed.) Request prior approval for enrolment Bevacizumab in combination with Paclitaxel and Carboplatin - Frontline Treatment (Previously Untreated) Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (This form must be completed before the first

More information

Corporate Presentation: Jefferies Global Healthcare Conference June 7, 2018

Corporate Presentation: Jefferies Global Healthcare Conference June 7, 2018 Corporate Presentation: Jefferies Global Healthcare Conference June 7, 2018 2018 CytomX Therapeutics, Inc. 1 Forward Looking Statements Special Note Regarding Forward-Looking Statements This presentation

More information

At the forefront of cancer immunotherapy. Investor Presentation January 2018

At the forefront of cancer immunotherapy. Investor Presentation January 2018 1 At the forefront of cancer immunotherapy Investor Presentation January 2018 Disclaimer Certain statements made in this presentation are forward looking statements within the meaning of the safe harbour

More information

LION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology

LION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology LION BIOTECHNOLOGIES Leadership & Innovation in Oncology Corporate Presentation June 2016 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private

More information

Corporate Presentation

Corporate Presentation Corporate Presentation June 2017 Forward-Looking Statements This presentation contains forward-looking statements reflecting management s current beliefs and expectations. These forward looking statements

More information

Dr. Andres Wiernik. Lung Cancer

Dr. Andres Wiernik. Lung Cancer Dr. Andres Wiernik Lung Cancer Lung Cancer Facts - Demographics World Incidence: 1 8 million / year World Mortality: 1 6 million / year 5-year survival rates vary from 4 17% depending on stage and regional

More information

Summary... 2 MELANOMA AND OTHER SKIN TUMOURS... 3

Summary... 2 MELANOMA AND OTHER SKIN TUMOURS... 3 ESMO 2016 Congress 7-11 October, 2016 Copenhagen, Denmark Table of Contents Summary... 2 MELANOMA AND OTHER SKIN TUMOURS... 3 Long-term results show adjuvant therapy with ipilimumab improves OS in high

More information

Conversations in Oncology. November Kerry Hotel Pudong, Shanghai China

Conversations in Oncology. November Kerry Hotel Pudong, Shanghai China Conversations in Oncology November 12-13 Kerry Hotel Pudong, Shanghai China Immunotherapy of Lung Cancer Professor Caicun Zhou All materials are for scientific exchanges. Afatinib and nintedanib are not

More information

Metastatic NSCLC: Expanding Role of Immunotherapy. Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian

Metastatic NSCLC: Expanding Role of Immunotherapy. Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian Metastatic NSCLC: Expanding Role of Immunotherapy Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian Disclosures: No relevant disclosures Please note that some of the studies reported in

More information

Monthly Oncology Tumor Boards: A Multidisciplinary Approach to Individualized Patient Care Lung Cancer: Advanced Disease March 8, 2016

Monthly Oncology Tumor Boards: A Multidisciplinary Approach to Individualized Patient Care Lung Cancer: Advanced Disease March 8, 2016 Monthly Oncology Tumor Boards: A Multidisciplinary Approach to Individualized Patient Care Lung Cancer: Advanced Disease March 8, 2016 Jae Kim, MD City of Hope Comprehensive Cancer Center Karen Reckamp,

More information

The Immunotherapy of Oncology

The Immunotherapy of Oncology The Immunotherapy of Oncology The 30-year Overnight Success Story M Avery, BIOtech Now 2014 Disclosures: Geoffrey R. Weiss, M.D. None The History A. Chekov: It has long been noted that the growth of malignant

More information

Tumor Antigens in the Age of Engineered T cell Therapies

Tumor Antigens in the Age of Engineered T cell Therapies Tumor Antigens in the Age of Engineered T cell Therapies September 30 th 2016 ESMO Preceptorship Course Amsterdam Carsten Linnemann, PhD Senior Scientist Kite Pharma EU B.V. Amsterdam Forward Looking Statements/Safe

More information

BEATcc Trial: ENGOT-Cx10 / GEICO 68-C / JGOG1084. GCIG Meeting

BEATcc Trial: ENGOT-Cx10 / GEICO 68-C / JGOG1084. GCIG Meeting BEATcc Trial: ENGOT-Cx10 / GEICO 68-C / JGOG1084 GCIG Meeting Ana Oaknin, MD PhD Head of Gynecologic Cancer Program. Vall d Hebron Institute of Oncology(VHIO). Vall d Hebron University Hospital. GEICO

More information

We re Reaching Ludicrous Speed: New Immunotherapy Oncology Medications

We re Reaching Ludicrous Speed: New Immunotherapy Oncology Medications We re Reaching Ludicrous Speed: New Immunotherapy Oncology Medications Adam Peele, PharmD, BCPS, BCOP Oncology Pharmacy Manager Cone Health Disclosures Merck Pharmaceuticals Speaker s Bureau 1 Objectives

More information

General Information, efficacy and safety data

General Information, efficacy and safety data Horizon Scanning in Oncology Horizon Scanning in Oncology 23 rd Prioritization 2 nd quarter 2015 General Information, efficacy and safety data Eleen Rothschedl Anna Nachtnebel Priorisierung XXIII HSS Onkologie

More information

6/7/16. Melanoma. Updates on immune checkpoint therapies. Molecularly targeted therapies. FDA approval for talimogene laherparepvec (T- VEC)

6/7/16. Melanoma. Updates on immune checkpoint therapies. Molecularly targeted therapies. FDA approval for talimogene laherparepvec (T- VEC) Melanoma John A Thompson MD July 17, 2016 Featuring: Updates on immune checkpoint therapies Molecularly targeted therapies FDA approval for talimogene laherparepvec (T- VEC) 1 Mechanism of ac-on of Ipilimumab

More information

for patients with ECOG PS 0-1 as indicated in the CheckMate-067 trial. Upon reconsideration of the Initial Recommendation, perc noted PAG s feedback requesting guidance on extrapolating eligibility to

More information

Determined to realize a future in which people with cancer live longer and better than ever before

Determined to realize a future in which people with cancer live longer and better than ever before Determined to realize a future in which people with cancer live longer and better than ever before 3Q 2018 EARNINGS PRESENTATION NOVEMBER 2018 1 Forward-looking statements disclosure This presentation

More information

Incorporating Immunotherapy into the treatment of NSCLC

Incorporating Immunotherapy into the treatment of NSCLC Incorporating Immunotherapy into the treatment of NSCLC Suresh S. Ramalingam, MD Roberto C. Goizueta Chair for Cancer Research Assistant Dean for Cancer Research Deputy Director, Winship Cancer Institute

More information

Immunotherapy for NSCLC: Current State of the Art and Future Directions. H. Jack West, MD Swedish Cancer Institute Seattle, Washington, United States

Immunotherapy for NSCLC: Current State of the Art and Future Directions. H. Jack West, MD Swedish Cancer Institute Seattle, Washington, United States Immunotherapy for NSCLC: Current State of the Art and Future Directions H. Jack West, MD Swedish Cancer Institute Seattle, Washington, United States Which of the following statements regarding immunotherapy

More information

Corporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers

Corporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers Corporate Presentation May 2016 Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers Forward-looking statements / safe harbor This presentation and the accompanying oral commentary contain

More information

More cancer patients are being treated with immunotherapy, but

More cancer patients are being treated with immunotherapy, but Bristol-Myers Squibb and Five Prime Present Phase 1a/1b Data Evaluating Cabiralizumab (anti-csf-1 receptor antibody) with Opdivo (nivolumab) in Patients with Advanced Solid Tumors PRINCETON, N.J. & SOUTH

More information

Immunotherapy, an exciting era!!

Immunotherapy, an exciting era!! Immunotherapy, an exciting era!! Yousef Zakharia MD University of Iowa and Holden Comprehensive Cancer Center Alliance Meeting, Chicago November 2016 Presentation Objectives l General approach to immunotherapy

More information

METRIC Study Key Eligibility Criteria

METRIC Study Key Eligibility Criteria The METRIC Study METRIC Study Key Eligibility Criteria The pivotal METRIC Study is evaluating glembatumumab vedotin in patients with gpnmb overexpressing metastatic triple-negative breast cancer (TNBC).

More information

PRO 140. First self-administered antibody therapy for HIV in late-stage clinical development. March

PRO 140. First self-administered antibody therapy for HIV in late-stage clinical development. March PRO 140 First self-administered antibody therapy for HIV in late-stage clinical development March 2018 Forward-Looking Statements This presentation includes forward-looking statements and forward-looking

More information